Rest Easy: Is Bed Rest Really Necessary After Surgical Repair of an Ankle Fracture?

This study has been completed.
Sponsor:
Collaborator:
National Trauma Research Institute
Information provided by:
The Alfred
ClinicalTrials.gov Identifier:
NCT00690651
First received: June 2, 2008
Last updated: June 8, 2010
Last verified: January 2010
  Purpose

After a patient has fractured an ankle that then requires surgery, the recommendation is to remain in bed, with the operated leg elevated on pillows for 48 hours. This is a precautionary measure, as yet unsubstantiated by research, which is thought to minimize ankle swelling that can inhibit the healing of the surgical wound. However, prolonged bed rest can lead to other complications such as blood clots in the lungs or leg veins, or chest infections such as pneumonia. Prolonged bed rest is also known to cause weakness and a loss of fitness such that recovery may be slower. In this research the investigators will be randomly allocating patients to mobilize within 24 hours post operatively or to rest in bed for 48 hours with their leg well elevated. The investigators will measure length of stay and wound healing and integrity at 14 days. This study aims to investigate whether getting patients out of bed within 24 hours of surgery can accelerate recovery and reduce acute hospital length of stay without affecting wound healing. If bed rest for 2 days is not necessary, there will be benefits for the patient in terms of general health and ability, and for the hospital in terms of cost savings through shorter lengths of stay and patient through put. The investigators already know that early mobilization is beneficial following other types of orthopedic surgery such as hip fractures. This study aims to investigate if early mobilization following surgical management of ankle fractures is safe with specific regard to wound integrity and wound outcomes. This study will also investigate the effect of earlier mobilization on the length of time spent in the acute hospital and for those discharged directly home, the amount and type of support required. If early mobilization is found to be safe for wound healing and results in shorter in-hospital stays, this research will provide the confidence to endorse a change to current clinical practice.


Condition Intervention
Ankle Injuries
Fracture
Procedure: Early mobilization
Procedure: Standard mobilization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study Into Early Mobilization Following Internal Fixation of Isolated Ankle Fractures.

Resource links provided by NLM:


Further study details as provided by The Alfred:

Primary Outcome Measures:
  • length of acute hospital stay [ Time Frame: various ] [ Designated as safety issue: No ]
    The time frame is variable as the length of stay is variable depending on many factors (usually less than a week in acute hospital if no complications)


Secondary Outcome Measures:
  • wound integrity [ Time Frame: 10-14 days ] [ Designated as safety issue: Yes ]
  • readmission rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: July 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
this group will rest in bed with operated leg well elevated for 48 hour and then mobilize with physiotherapist with aim for discharge home when safe.
Procedure: Standard mobilization
this group will rest in bed with their leg elevated above their heart for 48 hours post surgery to ankle fracture and will then mobilize with physiotherapist with aim to discharge home.
Experimental: 1
mobilize with physiotherapist within 24 hours of surgical fixation of fractured ankle
Procedure: Early mobilization
pt to get out of bed and mobilize with physiotherapist within 24 hours of surgery. they will be allowed toilet privileges and will go home when safe (as per medical staff and allied health)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who have had internal fixation of a fractured ankle closed without plastic surgery intervention and without follow up hyperbaric oxygen therapy

Exclusion Criteria:

  • living in nursing home,
  • previously non-ambulant,
  • concommitant injuries which do not allow early mobilisation, plastics involvement for wound closure, hyperbaric oxygen therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690651

Locations
Australia, Victoria
The Alfred
Melbourne, Victoria, Australia, 3204
Sponsors and Collaborators
The Alfred
National Trauma Research Institute
Investigators
Principal Investigator: Lara a Kmmel, BA. Physio Bayside Health
Study Director: Anne Holland, Dr Physio Bayside Health
  More Information

No publications provided

Responsible Party: Ms Lara kimmel, The Alfred
ClinicalTrials.gov Identifier: NCT00690651     History of Changes
Other Study ID Numbers: 166/08
Study First Received: June 2, 2008
Last Updated: June 8, 2010
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by The Alfred:
ankle
fracture
mobilisation
bed rest
internal fixation

Additional relevant MeSH terms:
Fractures, Bone
Ankle Injuries
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on April 17, 2014